Pfizer (PFE) Starts Late-Stage Study on Influenza Vaccine

PFE MRNA MORF BNTX

Pfizer, Inc. (PFE - Free Report) announced that it has started dosing participants in a pivotal phase III study, evaluating the efficacy, safety, tolerability and immunogenicity of its quadrivalent modified RNA (modRNA) influenza vaccine candidate.

Like its blockbuster COVID-19 vaccine Comirnaty, the influenza vaccine is being developed by Pfizer using mRNA technology leveraged from partner BioNTech (BNTX - Free Report) .

The initiation of this late-stage study is based on the data from the ongoing phase II study, which supports the candidate’s advancements in late-stage development. The phase III study is expected to enroll nearly 25,000 adult participants.

Unlike other diseases, the virus strains used in influenza vaccines must be changed annually to account for the evolving virus. Per management, mRNA technology allows changing vaccine strains relatively faster, as an mRNA-based vaccine only requires the genetic sequences of the virus it intends to target. Furthermore, the rapid manufacturing of mRNA-based vaccines may also allow better matching of the strains of a continuously evolving virus in the future.

Pfizer’s influenza vaccine candidate will encode strains of the influenza virus recommended by the World Health Organization (WHO) for the Northern Hemisphere 2022-23 cell culture- or recombinant-based influenza vaccines.

Shares of Pfizer have lost 21.9% in the year so far compared with the industry’s 4.0% decline.

The influenza vaccine was developed as part of a worldwide collaboration and license agreement between Pfizer and BioNTech in 2018. Per the terms of the agreement, Pfizer has been granted exclusive rights for clinical development and commercialization of the influenza vaccines developed using BioNTech’s mRNA technology. In consideration, BioNTech will be eligible to receive royalties on future vaccine sales following potential approval and successful commercialization.

Another company developing an mRNA-based influenza vaccine is Moderna (MRNA - Free Report) . Like Pfizer, Moderna also started dosing participants in a late-stage study evaluating its flu vaccine, mRNA-1010, earlier this year in June. MRNA intends to seek accelerated approval for this candidate next year.

Apart from mRNA-1010, Moderna is also evaluating two other seasonal influenza candidates, mRNA-1020 and mRNA-1030, in early-stage studies which target two major surface glycoproteins that help the influenza virus to infect.

 

Zacks Rank & Stocks to Consider

Pfizer currently carries a Zacks Rank #3 (Hold).A better-ranked stock in the overall healthcare sector is Morphic (MORF - Free Report) , which sports a Zacks Rank # (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.47 to $1.80. Loss estimates for 2023 have narrowed from $3.96 to $3.62 during the same period. Shares of Morphic have lost 39% in the year-to-date period.

Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.

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